DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16-21 and 23-36 are rejected under 35 U.S.C. 103 as being unpatentable over Zapol et al. 2018/0243527 in view of Morfill et al. 2012/0039747
Regarding claim 16, Zapol teaches a system for treating or preventing a viral, bacterial or fungal infection in the oral cavity or along the respiratory tract of a patient (0003 discusses the use of nitric oxide to treat different respiratory diseases, figure 5b depicts the treatment being applied inside of the oral cavity of the patient) by reactive species generated by plasma (the abstract states “Plasma generation can be done within the cartridge or within the controller.”), the system comprising: a plasma source generating reactive species in a gas (00184 states “The plasma chamber 22 includes one or more electrodes 24 therein that are configured to produce, with the use of a high voltage circuit 28, a product gas 32 containing a desired amount of NO from the reactant gas.”), the plasma source being configured to be located outside a body of the patient (plasma chamber is located within NO generator system 10, which is located outside); and a species directing member forming at least one duct configured to guide at least a part of the reactive species generated by the plasma source into at least one of the oral cavity and the respiratory tract (Figure 10 depicts a duct within t-fitting 216 that directs plasma generated from the plasma generator to a main air flow line that then gets carried to the patient), wherein the plasma source comprises a first electrode (Figure 44c, 662), a second electrode (664) and a dielectric member (insulative frame 666), wherein at least a part of the dielectric member is disposed between the first electrode and the second electrode (Depicted in figure 44c), wherein the first electrode is in the form of a laminar shaped high- voltage electrode (electrode 662 is in a sheet like planar structure that is made from sheet metal, specification of current application states that “the first electrode may be a laminar shaped high-voltage electrode. In other words, the first electrode may be provided as an essentially continuous sheet of conductive material, in particular a planar sheet”, therefore it can be considered Laminar based on the depicted structure in figure 44c. Furthermore, paragraph 0265 describes the use of high-voltage electrode assemblies within the device.).
Zapol fails to explicitly teach wherein the plasma source is configured to generate at least one of a non-thermal plasma and a cold atmospheric plasma.
Morfill teaches an analogous body treating device using plasma that does teach wherein the plasma source is configured to generate at least one of a non-thermal plasma and a cold atmospheric plasma (0094 states “FIGS. 9A and 9B show another preferred embodiment of a DBD electrode arrangement 1A for generating a non-thermal plasma.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zapol with the teachings of Morfill and include wherein the plasma source is configured to generate at least one of a non-thermal plasma and a cold atmospheric plasma, as it allows for the treatment of an affected area of the body of the user.
Regarding claim 17, Zapol teaches the system of claim 16, wherein the viral, bacterial or fungal infection is in the interior of the nose, throat, trachea or lungs of the patient (Figure 5b depicts the outside tubing located within the patient’s mouth).
Regarding claim 18, Zapol teaches the system of claim 16, wherein the duct comprises: a first end through which at least part of the reactive species generated by the plasma source enters the duct (Figure 10 depicts NO gas entering the T-fitting through an opening); and a second, open end through which at least part of said reactive species are released (Figure 5b depicts tubing within the patient’s mouth, the NO gas would exit through the opening within this tubing), wherein the first end is configured to be located outside the patient's body (the t-fitting is located outside the patient’s body) and the second end is configured to be located in the oral cavity or in the respiratory tract (the exit tubing in figure 5b is located in the patient’s mouth).
Regarding claim 19, Zapol teaches the system of claim 18, wherein the duct is at least partly formed by an elongate tubular member, wherein the tubular member has a length of at least 1 cm (Figure 5b depicts an elongate tubing member by way of the tubing member that enters the patient’s mouth, the tube is longer than 1 cm.).
Regarding claim 20, Zapol teaches the system of claim 18, wherein the tubular member has a length of at least 10 cm (The tubing member of 5b is longer than 10 cm).
Regarding claim 21, Zapol teaches the system of claim 18, wherein the tubular member has a length of at least 30 cm (the tubing member of 5b is longer than 30 cm).
Regarding claim 23, modified Zapol teaches the system of claim 22, but fails to teach wherein the second electrode is a mesh or comb shaped electrode. Morfill discloses an analogous plasma treatment device that does teach wherein the second electrode is a mesh or comb shaped electrode (0014 states “at least one of the first electrode and the second electrode comprises a wire-mesh, wherein the afore-mentioned perforations are arranged between individual meshes of the wire-mesh”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Zapol with the teachings of Morfill and include wherein the second electrode is a mesh or comb shaped electrode as a double mesh system is gas permeable and allows a gas flow can transversely penetrate the electrode arrangement (0014).
Regarding claim 24, Zapol teaches the system of claim 16, wherein the plasma source forms a duct-shaped portion through which the gas flows, wherein a first electrode of the plasma source is a part of the duct- shaped portion or constitutes the duct-shaped portion (Figure 10 depicts injector portion 200 receiving an NO gas flow from the plasma source as depicted in figure 7 where the plasma generator is placed directly before the filter and scavenger before being injected into the main gas flow. 0010 states “a nitric oxide generation system comprises one or more plasma chambers each including one or more electrodes configured to generate a product gas containing nitric oxide using a flow of a reactant gas through the one or more plasma chambers.” Based on the electrodes being contained within the plasma chamber, the electrodes would also be a part of the duct shaped portion as the gas that flows through the duct connecting the plasma generator with the injector portion 200 would also flow through the electrodes.).
Regarding claim 25, Zapol teaches the system of claim 24, wherein a second electrode of the plasma source is arranged along a main axis of the duct (0010 states that the plasma chambers contains one or more electrodes, meaning that a second electrode would also be in line with the duct portion).
Regarding claim 26, Zapol teaches the system of claim 16, further comprising a chamber disposed between the plasma source and the species directing member (Figure 10 depicts flow path 204 located between the plasma generator that enters 200 and the T-fitting of 216) , wherein the chamber comprises a chamber outlet opening (opening below check valves 212), and wherein a first end of the species directing member is fluidly connected to the chamber outlet opening (The t-fitting is connected to 200 via the opening below check valve 212).
Regarding claim 27, Zapol teaches the system of claim 26, wherein the chamber (Flow path 204) is formed in a chamber member (Scavenger cartridge 208), wherein the chamber member is manually detachable from the plasma source or manually removably connectable to the plasma source (0202 states “Each flow path can contain a scavenger cartridge 208, 210 that is removably connected”)
Regarding claim 28, Zapol teaches the system of claim 27, wherein the chamber member (Scavenger cartridge 208) is manually detachable from the plasma source or manually removably connectable to the plasma source via a snap-fit or friction-fit connection (0545 states “the scavenger cartridge connects directly to the ventilator cartridge to reduce pneumatic connections and decrease NO transit time while maintaining the ability to replace a scavenger cartridge without opening a patient's inspiratory circuit.” Based on this, the connection between the scavenger cartridge and the injection member would be some sort of friction fit as it would be easy to swap out.).
Regarding claim 29, Zapol teaches the system of claim 26, further comprising a gas flow generator configured to generate at least one of a gas flow through the species directing member and a gas flow into the chamber (0007 states “In some embodiments, the reactant gas source is in the form of a reservoir. In some embodiments, the reactant gas source is in the form of a pump”).
Regarding claim 30, Zapol teaches the system of claim 29, wherein the gas flow generator is a fan (0230 states “a flow source 478 connected to a plasma chamber where the flow source can be varied in flow rate, pressure or a combination of the two. The flow source could be a rotary pump, piston pump, blower, pressurized vessel, fan, etc.”).
Regarding claim 31, Zapol teaches the system of claim 29, wherein the gas flow generator is positioned outside the chamber (Figure 15 depicts air pump 284 located outside of the plasma generator).
Regarding claim 32, Zapol teaches the system of claim 31, wherein the gas flow generator is positioned outside the chamber upstream of the chamber (Figure 15 depicts air pump 284 located upstream of the chamber).
Regarding claim 33, Zapol teaches the system of claim 16, further comprising a gas source (0007 states “the reactant gas source is in the form of a reservoir”).
Regarding claim 34, Zapol teaches the system of claim 33, wherein the gas is pressurized in the gas source (0229 states “The pump is used to maintain a constant pressure in the air reservoir. A pressurized reservoir delivering air through a proportional valve can be more responsive and provide more instantaneous flow than a pump that needs to accelerate to speed.”).
Regarding claim 35, Zapol teaches the system of claim 16, wherein the system is a hand-held device (the system described in 5a and 5b can be held in someone’s hand).
Regarding claim 36, Zapol teaches a method for treatment or prevention of at least one of a viral, bacterial or fungal infection in the oral cavity or along the respiratory tract of a patient (0003 discusses the use of nitric oxide to treat different respiratory diseases, figure 5b depicts the treatment being applied inside of the oral cavity of the patient.), wherein the method comprises: providing a system in accordance with claim 16 (Device of Zapol); generating reactive species in a gas with a plasma source of the device being located outside a body of the patient (0005 states “a nitric oxide generation system comprises one or more plasma chambers each including one or more electrodes configured to generate a product gas containing nitric oxide using a flow of a reactant gas through the one or more plasma chambers.” The plasma generator is located outside of the body as depicted in figure 7, with the plasma generator being located outside the output gas connection); guiding at least a part of the reactive species generated by the plasma source into at least one of the oral cavity and the respiratory tract (Figure 10 depicts an injection of the reactive species into the main air flow, which then gets delivered to the oral cavity of the patient as depicted in figure 5b).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Zapol.
Regarding claim 22, modified Zapol teaches the system of claim 16, but the embodiment fails to teach wherein the second electrode is a structured ground electrode. Figure 46B of Zapol does teach an alternate electrode setup in which the second electrode 696 is a ground electrode. It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second electrode of 44C and make it into a ground electrode for the purpose of aiding in the stable production of NO (0276).
Claim 37-40 is rejected under 35 U.S.C. 103 as being unpatentable over Zapol in view of Gamache et al. 2023/0142973
Regarding claim 37, modified Zapol teaches the method of claim 36, but fails to explicitly teach wherein said viral infection is a viral infectious disease selected from the group consisting of infections by coronaviruses, influenza viruses, parainfluenza viruses, respiratory syncytial viruses (RSV), rhinoviruses, adenoviruses, noroviruses, enteroviruses, human metapneumoviruses, herpesviruses. Gamache teaches an analogous plasma treatment device (0038) that does teach wherein said viral infection is a viral infectious disease selected from the group consisting of infections by coronaviruses, influenza viruses, parainfluenza viruses, respiratory syncytial viruses (RSV), rhinoviruses, adenoviruses, noroviruses, enteroviruses, human metapneumoviruses, herpesviruses (0138 teaches “In some implementations, the virus includes a SARS virus. In some implementations, the SARS virus includes SARS-CoV-2.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Zapol with the teachings of Gamache and include the treatment of SARS through the reactive species as they are common respiratory ailments.
Regarding claim 38, modified Zapol teaches the method of claim 37, wherein the coronaviruses are SARS-CoV, SARS-CoV-2, MERS (0138 of Gamache teaches “In some implementations, the virus includes a SARS virus. In some implementations, the SARS virus includes SARS-CoV-2.”).
Regarding claim 39, modified Zapol teaches the method of claim 37, but fails to explicitly teach wherein the herpesviruses are HSV-1, HSV-2, VZV, EBV, HCMV, HHV-6, HHV-7, HHV-8. However, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Herpesviruses such as HSV-1, HSV-2, VZV, EBV, HCMV, HHV-6, HHV-7, HHV-8 are common respiratory ailments, due to the potential treatment of other types of respiratory ailments as stated in both Zapol and Gamache, the device would also be able to treat these types of Herpesviruses as any physician could slightly tweak the device settings to match the ailment that is possessed by the patient.
Regarding claim 40, modified Zapol teaches the method of claim 37, wherein said viral infectious disease is the virus infection disease COVID-19 caused by the coronavirus SARS-CoV-2 (0138 of Gamache teaches “In some implementations, the virus includes a SARS virus. In some implementations, the SARS virus includes SARS-CoV-2.”).
Response to Arguments
Applicant’s arguments with respect to claim 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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